Description of Event or Problem · 1
DISPARITY FOUND IN CERTAIN TRUEBALANCE BLOOD GLUCOSE MONITORING SYSTEM ("BGM"), MANUFACTURED BY NIPRO DIAGNOSTICS RECENTLY PURCHASED, WHERE THE RESULTS DISPLAYED ARE IN MMOL/L INSTEAD OF MG/DL AS PREFERRED IN THE UNITED STATES. AS PER THE TRUEBALANCE USER MANUAL, THIS SETTING IS FIXED BY THE MANUFACTURER AND CANNOT BE CHANGED BY THE CONSUMER. DETERMINING THE TYPE OF UNIT FROM THE PACKAGING ALONE IN NOT POSSIBLE, A TEST MUST BE DONE ON EACH UNIT INDIVIDUALLY. WHEN TESTING, THE MMOL/L RESULTS ARE MUCH LOWER THAN MG/DL RESULTS AND ARE DISPLAYED AS DECIMALS (5.5 MMOL/L OR 100 MG/DL). THIS COULD LEAD TO GREAT CONFUSION WITH OUR DIABETIC PTS, MANY OF WHICH ARE ELDERLY, WHO MAY NOT NOTICE THE DECIMAL POINT AND BASE THEIR TREATMENT ON THE INCORRECT RESULTS (E.G. 13.5 MMOL/L READ AS 135 MG/DL, ACTUAL RESULTS 243 MG/DL). WE IMMEDIATELY NOTIFIED THE VENDOR ON (B)(4), 2013. WE ARE IN THE PROCESS OF IDENTIFYING ALL LOT NUMBERS OF TRUEBALANCE MONITORS PURCHASED IN THE MONTHS OF (B)(4), HOWEVER, AT THIS MOMENT IN OUR INVESTIGATION WE HAVE BEEN ABLE TO SINGLE OUT LOT # KP0128TI WITH EXPIRATION DATE 1/31/2015 TO BE THOSE UNITS DISPLAYING RESULTS IN MMOL/L, AS WELL AS UNITS WITH CORRECTS RESULTS IN MG/DL. WE ARE NOT AWARE OF ANY ADVERSE OUTCOMES TO PTS AT THIS TIME, HOWEVER, THIS HAS THE POTENTIAL TO ADVERSELY AFFECT OVER (B)(4).